BriefCase

K220709

Aidoc Medical, Ltd. · cleared 2022-10-07 · product code QAS · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspected positive findings of complete Large Vessel Occlusion (LVO) - MCA-M1, PCA-P1, ACA-A1, ICA, Basilar; and Medium Vessel Occlusions (MeVO) - MCA-M2, MCA-proximal M3, PCA-P2, PCA-proximal P3, ACA-A2, ACA-proximal A3, and Vertebral-V4. BriefCase uses an artificial intelligence algorithm to analyze images and highlight cases with detected findings on a standalone desktop application in parallel to the ongoing standard of care image interpretation.”
Algorithmartificial intelligence, deep-learning algorithms
source quote (p.5)
“Both devices are artificial intelligence, deep-learning algorithms incorporated software packages for use with DICOM 3.0 compliant CT scanners, PACS, and radiology workstations.”
Adaptive (vs locked)No
source quote (p.5)
“Both devices are intended to aid in triage and prioritization of radiological images and utilize the same design of deep learning algorithm trained on medical images.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=342 cases · 5 site(s)

endpoints: sensitivity; specificity; BriefCase time-to-notification compared to the predicate device; Positive Predictive Value (PPV); Negative Predictive Value (NPV); Positive Likelihood Ratio (PLR); Negative Likelihood Ratio (NLR)

Reported performance (8 observations)

sensitivity91.3CI 83.6%, 96.2%
source quote (p.8)
“Sensitivity was 91.3% (95% CI: 83.6%, 96.2%)”
specificity85.6CI 80.6%, 89.7%
source quote (p.8)
“specificity was 85.6% (95% CI: 80.6%, 89.7%).”
time_to_resultas written: “Time-to-notification (BriefCase VO)”2.23CI 2.22-2.23
source quote (p.8)
“The BriefCase mean time-to-notification for VO was 2.23 minutes (95% CI: 2.22-2.23).”
time_to_resultas written: “Time-to-notification (predicate BriefCase LVO)”3.8CI 3.60-4.00
source quote (p.8)
“The time-to-notification for the predicate BriefCase LVO was 3.80 minutes (95% CI: 3.60-4.00).”
npvas written: “NPV”98.9CI 4.66%- 99.4%
source quote (p.9)
“NPV was 98.9% (95% CI: 4.66%- 99.4%)”
ppvas written: “PPV”41.3CI 34.1%- 49.0%
source quote (p.9)
“PPV was 41.3% (95% CI: 34.1%- 49.0%).”
ppvas written: “PLR”6.34CI 97.9%- 8.63%
source quote (p.9)
“PLR was 6.34% (95% CI: 97.9%- 8.63%)”
npvas written: “NLR”0.1CI 0.05%- 0.20%
source quote (p.9)
“NLR was 0.10% (95% CI: 0.05%- 0.20%).”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
18
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253578 (decision 2026-02-26) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253578

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251195 (decision 2026-01-27) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251195

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252970 (decision 2026-01-07) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage: CARE Multi-triage CT Body") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252970

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K253265 (decision 2025-11-06) from Aidoc Medical , Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K253265

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251406 (decision 2025-05-30) from Aidoc Medical, Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251406

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250248 (decision 2025-02-14) from Aidoc Medical, Ltd. for a matching device line ("BriefCase-Triage") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250248

  • …and 12 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K220709